UCB is a global biopharma company focusing on diseases in two therapeutic areas – CNS and Immunology. Described as a ‘patient-centric’ company, UCB central aim is to enable families with severe diseases to enjoy normal lives. As part of its corporate responsibility, compliancy with national and European Codes of Conduct for pharmaceutical industries remains a top priority. BMI SYSTEM therefore spoke to Stéphanie Viaud (Compliance and Regulatory Affairs Manager, UCB France), about the challenges the French affiliate has faced with the introduction of the Bertrand Law (aka the French Sunshine Act), which requires disclosure of transfers of value at the individual level.
1. UCB prides itself on putting the needs of patients at the forefront of its work. How important is it therefore for the company that it continues to work to improve transparency and remain compliant with the DMOS law?
Industry interactions with the medical profession have a profound and positive influence on the quality of patient’s treatment and on the value of future research. Integrity is one of the most important values at UCB. At the same time, the integrity of the decisions of a HCP to prescribe a medicine is one of the pillars of the healthcare system. UCB France works to respect transparency and the DMOS law to create a better understanding of, and ultimately build trust in, the validity of industry interactions with the medical profession. The aim is to ensure that these interactions meet the high standards of integrity that patients, governments and other stakeholders expect.
2. Recent changes in the French Bertrand law mean that transfers of value needed to be publicly disclosed on an individual basis from last year. How did UCB France prepare to meet this requirement?
Since 2010, UCB France has implemented an IT system to ensure a high traceability of all interactions with HCPs. The use of BMI SYSTEM’s NAYA software has allowed the data to be centralised and has also simplified the tracking, approval and control of interactions with HCPs so that individual disclosure can be accomplished.
3. How important has it been for UCB France to have a well-designed and robust IT system that can record and check data on transfers of value?
Capturing data has not been a challenge as NAYA has been in place for a few years in the affiliate; however BMI SYSTEM’s expertise has been valuable for extracting data and building reports on transfers of value.
4. In an international company, what are the challenges of cross border data collection and the need to remain compliant with a number of national codes of conduct?
To manage cross border activities, it is essential to have corporate rules in place but also to help users to know these rules (which differ by country). The key in this case, is to have an IT system to manage the cross border requests, which integrates rules applicable to each country.
5. What are the main challenges for UCB France in terms of transparency, which have driven the choice of the software solution to be used?
The main challenge in terms of transparency is to ensure data accuracy and completeness. There is a large bulk of data that has to be collected and reviewed on a daily basis for transparency issues. The software solution we have chosen (NAYA) is able to deal with these large volumes of data and allow daily control and arbitration of each event. This functionality ensures data accuracy and completeness to create reports on transfers of value.
6. Why choose NAYA? UCB France chose NAYA as the tool was totally in line with the French requirements for the DMOS law and transparency. Moreover, BMI SYSTEM’s technology could collect data from other IT systems and integrate it into one system. NAYA is very simple and user-friendly tool that can be adapted to the workflow in place in the company.
7. What impact has NAYA had on your processes and the way you manage transparency (DMOS laws in France)?
The implementation of NAYA at UCB France was based on the organisation in place in the company. NAYA provided a solution to enable an automatised validation workflow between the sales team and the headquarters. Since the implementation of the system, we have limited the exchange of e-mails or phone calls to collect information. NAYA is now our unique reference for managing details on all financial interactions with HCPs.
8. What is, for you, the main advantage of NAYA in terms of data aggregation for public disclosure?
As the data are fully collected, reviewed and approved on a daily basis in the NAYA system, when it is time to extract data for disclosure, we are sure that it is both complete and accurate.
9. Do you think you would have been able to cope with the latest French Bertrand Law on transparency and public disclosure without the help of the NAYA tool?
Without the NAYA system in place, UCB France would not be able to respect the deadlines required by the French Bertrand Law on transparency and public disclosure. Furthermore, the company would have to invest a lot more resources into the collection, aggregation and review of data for disclosure.